Status:
NOT_YET_RECRUITING
A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy
Lead Sponsor:
Norgine
Collaborating Sponsors:
Parexel
Conditions:
Bowel Cleansing Prior to Clinical Procedures
Eligibility:
All Genders
1-17 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to assess the efficacy, safety and tolerability of PLENVU® by measuring its bowel cleansing success rate compared to sodium picosulfate in paediatric participants aged less...
Detailed Description
This is a multicentre, active-controlled study in which the participants will be randomised 1:1 into one of two treatment groups - PLENVU® or sodium picosulfate in a 2-day split dosing regimen. The st...
Eligibility Criteria
Inclusion
- Participants who require a colonoscopy.
- Must weigh a minimum of 10 kg, and participants aged 1 to \< 4 years of age must be above the 10th percentile of weight for age.
- Must have a negative urine pregnancy test (or serum if a urine pregnancy test cannot be confirmed as negative \[e.g. three ambiguous results\]) within 24 hours before the first dose of study intervention.
- Must use a highly effective method of contraception (failure rate \< 1% per year) from Day 1 and throughout the Safety Follow-up Period.
- Must not be breastfeeding.
- Participant is able to receive regular external feeding without breastfeeding.
Exclusion
- Has a past history within last 12 months or current episode of severe constipation (requiring repeated use of laxatives/enema or physical intervention before resolution).
- Has known or suspected ileus, GI obstruction, gastric retention, bowel perforation, toxic colitis, ischaemic colitis, or megacolon.
- Has ongoing severe acute inflammatory bowel disease that contraindicates colonoscopy.
- Participant has history of significant GI surgeries.
- Has known glucose-6-phosphate dehydrogenase (G6PD) deficiency or phenylketonuria.
- Participant has a past history within the last 12 months or evidence of any ongoing clinically relevant electrocardiogram (ECG) abnormalities (e.g. arrhythmias).
- Has a history of uncontrolled hypertension.
- Participant has regularly used laxatives or colon motility altering drugs in the last month (i.e. more than two times per week) and/or has used one or more laxatives within 72 hours prior to administration of the preparation.
- Has known hypersensitivity or allergic reaction to PEG, ascorbic acid, sodium picosulfate, magnesium oxide, or any other component of the investigational product or comparator.
- Received or scheduled to receive any vaccines or devices within one week prior to first dose of study intervention.
- Has a significant neurological disorder or a past history of seizures (excluding simple febrile seizures) or is currently on medication lowering seizure threshold (e.g. tricyclic antidepressants) or has used seizure threshold lowering medication within 14 days prior to administration of the preparation.
Key Trial Info
Start Date :
December 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 6 2027
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT07218523
Start Date
December 8 2025
End Date
January 6 2027
Last Update
October 20 2025
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